Recruitment closed APRIL 2018
Trial Status: Complete
This is a multi-centre Phase I trial of pre-operative, margin intensive, stereotactic body radiation therapy (SBRT) for previously untreated borderline resectable pancreatic cancer.
Phase I rolling six design dose escalation study testing the use of Stereotactic Body Radiation Therapy (SBRT) delivered in the pre-operative setting for pancreatic cancers.
- To establish the maximum tolerated dose (MTD) of margin-intensive SBRT delivered pre-operatively in the management of pancreatic cancer
- To examine key clinical outcomes for patients treated with this regimen, namely:
- Surgical resection rates
- Resection margin status
- Response rates
- Late SBRT toxicity (>1 month to 6 months post-surgery or to 6 months post SBRT for patients not proceeding to surgery)
- Efficacy and long term safety of SBRT delivered pre-operatively in the management of pancreatic cancer
First site open to recruitment: 17 April 2015
Planned accrual completion: 17 April 2017
Trial duration: 39 months
The study protocol publication can be found here.